Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects

Trial Profile

Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Dec 2016

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Cinfa Biotech
  • Most Recent Events

    • 06 Dec 2016 Primary endpoint has been met. (PD parameter ANC) as per results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 06 Dec 2016 Primary endpoint has been met. (PK parameter Cmax) as per results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 06 Dec 2016 Primary endpoint has been met. (PK parameter AUC0-last) as per results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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